Adjuvant Chemotherapy With S-1 Plus Oxaliplatin Versus S-1 Alone in Locally Advanced Gastric Cancer (RESCUE-GC)

December 11, 2018 updated by: Biao Fan, MD, PhD, Peking University Cancer Hospital & Institute

A Randomized, Multicentral, Controlled, Phase III Study to Compare Adjuvant Chemotherapy With S-1 Plus Oxaliplatin to S-1 Alone After Curative Distal Gastrectomy in Locally Advanced Gastric Cancer

The purpose of the study is to evaluate the efficacy and safety of S-1 plus Oxaliplatin versus S-1 only as adjuvant chemotherapy after curative distal gastrectomy in patients with locally advanced gastric cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is a multi-central, controlled, randomized Phase III trial. The protocol has been approved by the Ethics Committee of Beijing Cancer Hospital. The primary endpoint is the 3-year progression-free survival (PFS) rate. The secondary endpoints are the overall survival (OS) and safety.

Study Type

Interventional

Enrollment (Anticipated)

564

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jiafu Ji, MD
        • Sub-Investigator:
          • Zhaode Bu, MD
        • Sub-Investigator:
          • Biao Fan, MD
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Hospital Chinese Acadamy of Medical Sciences
        • Contact:
          • Dongbing Zhao, MD
        • Contact:
          • Lin Yang, MD
      • Beijing, Beijing, China, 100034
      • Beijing, Beijing, China, 100044
      • Beijing, Beijing, China, 100050
        • Not yet recruiting
        • Beijing Friendship Hospital
        • Contact:
      • Beijing, Beijing, China, 100053
      • Beijing, Beijing, China, 100730
        • Not yet recruiting
        • Beijing Hospital
        • Contact:
      • Beijing, Beijing, China, 100853
        • Not yet recruiting
        • Chinese PLA General Hospital
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430071
        • Not yet recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Not yet recruiting
        • Nanjing General Hospital
        • Contact:
    • Liaoning
      • Daliang, Liaoning, China, 116011
        • Recruiting
        • The First Affiliated Hospital of Daliang Medical University
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250012
        • Not yet recruiting
        • Qilu Hospital of Shandong University
        • Contact:
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
        • Contact:
      • Wenzhou, Zhejiang, China, 325000
        • Not yet recruiting
        • The Second Affiliated Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • sign written informed consent form
  • age ≥ 18 years, ≤69 years
  • ECOG status: 0~2
  • pathologically confirmed gastric cancer at stage II or IIIA (AJCC 7th version)
  • negative peritoneal cytology
  • underwent curative distal gastrectomy with D2 lymph node dissection
  • no prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immune therapy or target therapy
  • adequate organ function as defined below: Hematologic ANC ≥ 2*109/L, Platelets ≥ 100*109/L, AST and ALT ≤ 2.5×ULN, TBIL ≤ 1.5×ULN.

Exclusion Criteria:

  • be enrolled in other clinical trials
  • underwent prior antitumor treatment
  • allergic reaction to S-1 or oxaliplatin
  • abnormal GI tract function
  • female in pregnancy or lactation, or refuse to receive Contraception measures during chemotherapy
  • other situation to be judged not adaptive to the study by investigators

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A: postoperative Oxaliplatin plus S-1

Patients in arm A will receive standard distal gastrectomy with D2 lymphadenectomy first, and 8 cycles of adjuvant Oxaliplatin plus S-1 (SOX) later.

Oxaliplatin: 130mg/m2, iv drip for 2h, d1, q3W S-1: 40~60mg bid, po, d1~14, q3W (6 months)
Drug: Oxaliplatin plus S-1
8 cycles of adjuvant chemotherapy with Oxaliplatin plus S-1
Other Names:
  • SOX
Active Comparator: B: postoperative S-1 only

Patients in arm B will receive standard distal gastrectomy with D2 lymphadenectomy first, and 16 cycles of adjuvant S-1 later.

S-1: 40~60mg bid, po, d1~14, q3W (12 months)
Drug: S-1 only
16 cycles of adjuvant chemotherapy with S-1 only
Other Names:
  • S-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
disease-free survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: up to 5 years
To evaluate the 1-year, 3-year and 5-year overall survival of GC patients underwent post-operative chemotherapy of S-1 compared with post-operative SOX
up to 5 years
Incidence of Treatment-Emergent Adverse Events [Safety]
Time Frame: 1 year
The incidence of chemotherapy related adverse events in GC patients underwent post-operative chemotherapy of S-1 compared with post-operative SOX
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Cancer Hospital & Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2017

Primary Completion (Anticipated)

February 10, 2022

Study Completion (Anticipated)

February 10, 2024

Study Registration Dates

First Submitted

August 4, 2016

First Submitted That Met QC Criteria

August 15, 2016

First Posted (Estimate)

August 16, 2016

Study Record Updates

Last Update Posted (Actual)

December 12, 2018

Last Update Submitted That Met QC Criteria

December 11, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RESCUE-GC-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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